Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT06025669
Eligibility Criteria:
Inclusion Criteria:
1. healthy, typically developing, Intelligence quotient (IQ) ≥ 85;
2. never diagnosed with emotional-behavioral problems;
3. sleeping on a regular daily schedule;
4. reported napping three or more times every week, ≤ one nap in one day;
5. able to fall asleep by themselves.
Exclusion Criteria:
1. not able to fall asleep alone;
2. travel beyond two time zones within 3 months of the study;
3. use of medications influencing sleep or alertness;
4. reported or diagnosed sleep problems (such as obstructive sleep apnea (OSA), narcolepsy, parasomnia, insomnia, etc.) ;
5. history of neurodevelopmental diseases, including developmental delay, epilepsy, chronic medical conditions, lead poisoning and head injuries involving loss of consciousness;
6. conceptual age \<35 weeks or \> 45 weeks;
7. birth weight \< 2,500 grams;
8. Children's Behaviors Checklist (CBCL) total score \> 70;
9. a first-degree family history of diagnosed narcolepsy, psychosis or bipolar disorder.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
42 Months
Maximum Age:
72 Months
Study:
NCT06025669
Study Brief:
Protocol Section:
NCT06025669